FDA Adverse Event
Injury
Summary report: N
IDENTITY ADX SR
MDR report key: 1073375
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02164
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 14, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND HIGH CURRENT DRAIN DUE TO A DEFECTIVE INTERGRATED CIRCUIT RESULTING IN PREMATURE BATTERY DEPLETION. AFTER REPLACING THE INTERGRATED CIRCUIT, NORMAL FUNCTION ENSUED.
Description of Event or Problem · 1
THE PATIENT PRESENTED TO THE CLINIC FOR A FOLLOW-UP IN 2008. HE FELT THAT THE PULSE GENERATOR HAD MIGRATED. THE DEVICE WAS CHECKED AND APPEARED FINE. ABOUT 3 WEEKS LATER, THE PATIENT COMPLAINED OF PAIN AT THE SITE. THE DEVICE WAS SUBSEQUENTLY REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY ADX SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5180 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |